Rhodes 2006.

Methods	Study design: randomised controlled trial Randomisation method: consenting women were randomly assigned in a 1:1 ratio. Treatment assignment was ascertained by the research assistant by opening sealed randomisation envelopes in sequential order. The envelopes were prepared from a randomisation list generated by computer in blocks of size 10 to ensure balance between groups over short time spans such as shifts and days of the week as well as over the entire course of the study Power calculation: no Study dates: from June 2001 to December 2002
Participants	Setting: 2 socio‐economically diverse EDs – an urban academic medical centre serving mainly publicly insured inner city African‐American population and a suburban community hospital serving a privately insured suburban white population Country: USA Inclusion criteria: consenting women, aged 18 to 65 years, triaged as medically non‐emergent Exclusion criteria: none stated Number (%) of eligible recruited: 1281/2165 (59.2%) Numbers recruited: 1281; intervention group 637, control group 644 Number of dropouts: intervention group 216, control group 194 Numbers analysed (% recruited): 871; intervention group 421 (66.1%), control group 450 (70%) (based on audio‐recording data) Age: mean 33.3 years (SD 12 years) Marital status: married 21%, single 45%, divorced/separated/widowed 13%, unknown 21% Ethnicity: African‐American 60%, white 29%, other 7%, unknown 4% Socioeconomic status: < USD 20,000 40%, USD 20,000 to 39,999 24%, USD 40,000 to 79,999 16%, ≥ USD 80,000 8% Education: 1 < high school diploma 10%, high school or equivalent 18%, > high school 48%, unknown 24% Positive IPV screen result on exit questionnaire: 218/903 (24%); urban 151/578 (26%), suburban 67/325 (20.6%)
Interventions	Intervention group Self administered computer‐based health risk assessment (Promote Health Survey), which generated health recommendations for participants and alerted physicians to various potential health risks, including domestic violence. If the woman answered 'yes' to any of the 8 IPV assessment items, then the report generated for the physician had a prompt 'Possible partner violence: assess for current abuse' and suggested referral options Control group Usual ED care
Outcomes	Primary outcomes Discussion of IPV Disclosure of IPV to HCP Provision of domestic violence services Data were collected through audio‐recording of consultations (primary method). Data were also abstracted from medical records and collected directly from participants
Notes	Funding: Grant RO1 HS 11096‐03 from the Agency for Healthcare Research and Quality. Dr Rhodes was also supported by grant K23/ MH64572 from the National Institute of Mental Health
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The randomisation for participating patients was generated by "computer in blocks of size 10 to ensure balance between groups over short time spans, such as shifts and days of the week, as well as over the entire course of the study."
Allocation concealment (selection bias)	Low risk	Women were recruited and consented prior to the "research assistant opening sealed randomization envelopes in sequential order." "Consenting patients were then randomly assigned"
Blinding of participants and personnel (performance bias) All outcomes	High risk	Providers were not blinded to the purpose of the study or the intervention: "health care providers were informed that the study objective was to study the effect of a computer prompt on IPV communication and were encouraged to screen all women for abuse." However, this was unlikely to have led to benefits extraneous to the intended effect of the intervention for women in the intervention group; the outcome of interest is unlikely to have been influenced by lack of blinding. Women were blinded to the purpose of the study being told it was a "study of physician‐patient communication." Women in the intervention group may have realised that the computer‐based health risk assessment was part of the intervention thus influencing how they behaved. However, we would not expect that the outcome would have been influenced by this incomplete blinding. For example, changes in women's behaviour such as being more encouraged to discuss IPV with the HCP would not differ from what would be expected to arise from the intervention. Lack of blinding in the situation where participants in the control group inadvertently became aware of the intervention through interactions with other women or staff could conceivably have influenced the outcome. We are not given sufficient information about the degree of awareness of other staff regarding women's allocations, which could have influenced their interactions with women and, therefore, the outcomes
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	We are not told about who edited the audio‐recordings of the ED visits "a 7‐hour ED visit might be edited to 20 minutes of actual health care provider–patient interaction"; it would have been important for them to be blinded as knowing the allocation could have affected the editing process. Although research assistants who were to undertake the primary data collection via coding of audio‐recordings of both intervention and control group consultations were said to be blinded, the allocation of participants could have been revealed during the remaining audio data and thereby influenced coders' interpretation of what they heard. It is also not known if the person who edited differed from the coders. If the coder was also the editor then it would have increased the likelihood that the allocation of the participant would have become known. "Charts of all enrolled patients were coded using a structured chart abstraction form to assess evidence of DV documentation;" however, there is no indication of blinding of assessors. It is likely that the allocations of women in the intervention group were quite evident by virtue of presence of the IPV risk report and it is unclear if presence of a report was considered different to other documentation of IPV. Finally, both groups of women self completed an exit survey and were not blinded; however, any effect was likely equal in both groups
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	21/101 (21%) providers did not consent to having their consultations recorded and thus there was incomplete outcome data for their participants. However, this lack of recording should have been equal in both groups since providers were seeing participants in both the intervention and the control groups. The overall attrition of participants was 32% and we are not given clear information about the extent to which the providers' refusal to audio‐record sessions accounted for this rate (i.e. what proportion of patients declined the audio‐recording post‐randomisation). While the attrition levels in audio‐recording appear balanced across the two groups: 216/637 (intervention group 34%), 194/644 (control group 30.1%), there was no sensitivity analysis included in the report to ascertain the impact of those missing data on the robustness of the effect. Attrition rates on chart review were similarly spread and low at 8%, and moderately high but spread on the exit survey. There is a lack of information on reasons for these (albeit low) attrition rates in the chart review. There were four cases in the control group that appear in the participant flowchart but are absent from the observed rates in Table 3
Selective reporting (reporting bias)	Unclear risk	Data on medical records were not furnished except that it is indicated in the text that there was no difference between groups on the documentation of IPV. No reference to a trial protocol and thus no confirmation that the original trial aims and primary outcomes were as reported here
Other bias	High risk	Protection against contamination: the same providers delivered the intervention or usual care to participants. While they should have remained unaware of who the participants were in the control group, their experience of consulting with participants in the intervention group could have influenced their performance with the participants in the control group